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Finasteride Patent Expiration

Finasteride is used for treating male pattern baldness and androgenic alopecia. It was first introduced by Organon Llc A Sub Of Organon And Co in its drug Proscar on Jun 19, 1992. Another drug containing Finasteride is Propecia. 18 different companies have introduced drugs containing Finasteride.


Finasteride Patents

Given below is the list of patents protecting Finasteride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Proscar US5942519 Prevention of precipitated acute urinary retention Oct 23, 2018

(Expired)

 Organon
Propecia US5571817 Methods of treating androgenic alopecia with finasteride [17β-N-mono-substituted-carbamoyl-4-aza-5-α-androst-1-en-ones] Nov 05, 2013

(Expired)

 Organon
Propecia US5547957 Method of treating androgenic alopecia with 5-α reductase inhibitors Oct 15, 2013

(Expired)

 Organon
Propecia US5886184 Finasteride processes Nov 19, 2012

(Expired)

 Organon
Proscar US5886184 Finasteride processes Nov 19, 2012

(Expired)

 Organon



Finasteride's Family Patents

Family Patents

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Finasteride Generic API Manufacturers

Several generic applications have been filed for Finasteride. The first generic version for Finasteride was by Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa and was approved on Jun 19, 2006. And the latest generic version is by Alkem Laboratories Ltd and was approved on Jan 6, 2017.

Given below is the list of companies who have filed for Finasteride generic, along with the locations of their manufacturing plants worldwide.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 2 different strengths of generic version for Finasteride. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB Feb 23, 2010
1MG

tablet Prescription ORAL AB Nov 5, 2013





2. ACTAVIS TOTOWA

Actavis Totowa Llc has filed for 1 generic for Finasteride. Given below are the details of the strengths of this generic introduced by Actavis Totowa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG

tablet Discontinued ORAL N/A Nov 5, 2013


Manufacturing Plant Locations
New

Actavis Totowa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Actavis Totowa as present at those locations.

Country City Firm Name
United States
Totowa Actavis Totowa LLC
Little Falls Actavis Totowa LLC





3. ACTAVIS TOTOWA TEVA

Actavis Totowa Llc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 1 generic for Finasteride. Given below are the details of the strengths of this generic introduced by Actavis Totowa Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Discontinued ORAL N/A Mar 28, 2007





4. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Finasteride. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB Jan 5, 2017
1MG

tablet Prescription ORAL AB Jan 6, 2017





5. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Finasteride. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB Oct 30, 2007


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
Sangareddy Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
United States
East Windsor Aurobindo Pharma USA Inc





6. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 1 generic for Finasteride. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG

tablet Prescription ORAL AB Nov 5, 2013


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





7. CIPLA

Cipla Ltd has filed for 1 generic for Finasteride. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG

tablet Discontinued ORAL N/A Nov 20, 2014


Manufacturing Plant Locations
New

Cipla's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Cipla as present at those locations.

Country City Firm Name
India
Bangalore Cipla Ltd.
Bengaluru Cipla Limited
Pithampur, District Dhar Cipla Limited
Raigad Cipla Limited
Mumbai Cipla Limited
Kurkumbh Village, Dist. Pune Cipla, Ltd.
Vasco Da Gama Cipla Limited





8. DR REDDYS LABS INC

Dr Reddys Laboratories Inc has filed for 1 generic for Finasteride. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG

tablet Prescription ORAL AB Jul 28, 2006





9. DR REDDYS LABS LTD

Dr Reddys Laboratories Ltd has filed for 1 generic for Finasteride. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB Feb 28, 2007





10. GEDEON RICHTER USA

Gedeon Richter Usa Inc has filed for 1 generic for Finasteride. Given below are the details of the strengths of this generic introduced by Gedeon Richter Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Discontinued ORAL N/A Dec 22, 2006





11. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 2 different strengths of generic version for Finasteride. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB Jun 7, 2010
1MG

tablet Prescription ORAL AB Jul 1, 2013





12. IVAX SUB TEVA PHARMS

Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa has filed for 1 generic for Finasteride. Given below are the details of the strengths of this generic introduced by Ivax Sub Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Discontinued ORAL N/A Jun 19, 2006





13. MYLAN

Mylan Pharmaceuticals Inc has filed for 1 generic for Finasteride. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Discontinued ORAL N/A Dec 18, 2006


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Morgantown Mylan Specialty, L.P.
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Greensboro Mylan Pharmaceuticals Inc
San Carlos Mylan Pharmaceuticals Inc.
Saint Albans Mylan Technologies, Inc.
India
Bangalore Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





14. NATCO PHARMA

Natco Pharma Ltd has filed for 1 generic for Finasteride. Given below are the details of the strengths of this generic introduced by Natco Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG

tablet Discontinued ORAL N/A Nov 5, 2013


Manufacturing Plant Locations
New

Natco Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Natco Pharma as present at those locations.

Country City Firm Name
India
Hyderabad Natco Pharma Limited
Rangareddy District Natco Pharma Ltd. - Chemical Division
Rangareddy NATCO Pharma Limited
Hyderabad NATCO PHARMA LTD
Paravada Natco Pharma Limited
Chennai NATCO Pharma Limited Chemical Division Chennai





15. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Finasteride. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB Aug 16, 2011
1MG

tablet Prescription ORAL AB Jul 1, 2013


Manufacturing Plant Locations
New

Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.

Country City Firm Name
United States
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Billerica Sun Pharmaceutical Industries, Inc.
Lexington Sun Pharmaceutical Industries Inc
India
Punjab Sun Pharmaceutical Industries, Inc.
Dadra Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Baruch Sun Pharmaceutical Industries Ltd.
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Vadodara Sun Pharmaceutical Industries Ltd
Vadodara Sun Pharmaceutical Industries Ltd.
Ahmednagar Sun Pharmaceutical Industries Limited
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
New Delhi Sun Pharmaceutical Industries Limited
Halol Sun Pharmaceutical Industries Ltd.
Mohali Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Bharuch Sun Pharmaceutical Industries Ltd





16. TEVA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Finasteride. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB Dec 15, 2006
1MG

tablet Discontinued ORAL N/A Nov 5, 2013


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Miami Teva Branded Pharmaceutical Products R & D, Inc.
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Fort Dodge TEVA Animal Health Inc
Horsham Teva Branded Pharmaceutical Products R&D
India
Bhind Teva API India Ltd- Malanpur
Gajraula, Amroha Teva API India Private Ltd.
Canada
Markham Teva Canada Limited
Scarborough Teva Canada Limited
Stouffville Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





17. ZYDUS PHARMS USA INC

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Finasteride. Given below are the details of the strengths of this generic introduced by Zydus Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB Dec 28, 2009